We Asked 34 Cigar Companies About FDA, Here are the Results

Prior to the IPCPR Convention & Trade Show, I asked our readers if there was anything they’d like to see us cover that we didn’t already do. The overwhelming response was readers wanted to know more about how cigar companies were dealing with the U.S. Food & Drug Administration’s (FDA) deeming regulations, which went into effect last August.

As such, we developed a short 10-question multiple choice survey that cigar companies were asked to fill out anonymously. In the end, we got results back from 34 companies, which probably represented just over a quarter of all the cigar companies at the annual trade show.

The results are interesting and while there may not be any surprises, they do confirm that companies with large revenue are handling FDA differently compared to those with smaller revenue.

Highlights include:

44 percent of all companies say they have not met with FDA in any capacity

44 percent of companies indicate they have not submitted any products for grandfathering or substantial equivalence

None of the 18 companies generating less than $5 million in revenue indicated they had discontinued a single product because of FDA regulations

Five of the 34 companies surveyed indicated they introduced at least 1,000 new phantom cigars, SKUs that were released in small quantities prior to Aug. 8, 2016 solely to meet a deadline set by FDA regarding whether products must be pre-approved before they are allowed on the market.

The full results are published below in the exact order that we asked companies, additionally, I’ve provided a breakdown of responses based on how companies defined their revenue.

Please note: two of the 34 companies declined to answer any questions. Their surveys were left blank and tabulated. A few respondents answered some questions but declined to answer others. We told participants that they were free to leave any and all questions blank they did not feel comfortable answering.

FULL SURVEY (34 COMPANIES)

What is the annual revenue of the company?

Under $5 million: 52.94 percent

$5-10 million: 11.76 percent

Over $10 million: 17.65 percent

Declined to Answer: 17.65 percent

How has the company handled its FDA compliance process to date? (Mark all that apply)

Without Assistance: 14.71 percent

Hired an Attorney: 73.53 percent

Hired a non-legal Firm: 11.76 percent

Hired a Laboratory: 14.71 percent

Declined to Answer: 5.88 percent

Has the company submitted a grandfather or substantial equivalence submission?

Yes: 47.06 percent

No: 44.12 percent

Declined to Answer: 8.82 percent

Has the company met directly with FDA? (Mark all that apply)

Yes (In Person): 11.76 percent

Yes (Via Phone): 29.41 percent

Yes (Via Email): 32.35 percent

No: 44.12 percent

Declined to Answer: 5.88 percent

Is there a person working at the company whose primary responsibility is FDA compliance?

Yes: 64.71 percent

No: 26.47 percent

Declined to Answer: 5.88 percent

Has the company increased prices directly due to FDA-related costs?

Yes: 35.29 percent

No: 58.82 percent

Declined to Answer: 5.88 percent

Does the company intend on discontinuing products because of FDA deeming rules?

Yes: 26.47 percent

No: 64.71 percent

Declined to Answer: 8.82 percent

Has the company already discontinued products because of FDA deeming rules?

Yes: 11.76 percent

No: 79.41 percent

Declined to Answer: 8.82 percent

How many SKUs did the company introduce prior to Aug. 8, 2016 with the intention of marketing them more fully at a later date?

Less than 100: 55.88 percent

100-500: 17.65 percent

500-1,000: 2.94 percent

More than 1,000: 14.71 percent

Declined to Answer: 8.82 percent

Within the last 12 months has anyone from the company met directly with a U.S. Congressmen or Senator about FDA regulations?

Yes: 50 percent

No: 44.12 percent

Declined to Answer: 5.88 percent

COMPANIES GENERATING UNDER $5 MILLION IN REVENUE (18 COMPANIES)

How has the company handled its FDA compliance process to date? (Mark all that apply)

Without Assistance: 27.78 percent

Hired an Attorney: 66.67 percent

Hired a non-legal Firm: 11.1 percent

Hired a Laboratory: 11.11 percent

Declined to Answer: 0

Has the company submitted a grandfather or substantial equivalence submission?

Yes: 44.44 percent

No: 50 percent

Declined to Answer: 5.56 percent

Has the company met directly with FDA? (Mark all that apply)

Yes (In Person): 16.67 percent

Yes (Via Phone): 27.78 percent

Yes (Via Email): 38.89 percent

No: 38.89 percent

Declined to Answer: 0

Is there a person working at the company whose primary responsibility is FDA compliance?

Yes: 61.11 percent

No: 38.89 percent

Declined to Answer: 0

Has the company increased prices directly due to FDA-related costs?

Yes: 22.22 percent

No: 77.78 percent

Declined to Answer: 0

Does the company intend on discontinuing products because of FDA deeming rules?

Yes: 16.67 percent

No: 77.78 percent

Declined to Answer: 0 percent

Has the company already discontinued products because of FDA deeming rules?

Yes: 0 percent

No: 100 percent

Declined to Answer: 0

How many SKUs did the company introduce prior to Aug. 8, 2016 with the intention of marketing them more fully at a later date?

Less than 100: 83.33 percent

100-500: 11.11 percent

500-1,000: 0 percent

More than 1,000: 5.56 percent

Declined to Answer: 0

Within the last 12 months has anyone from the company met directly with a U.S. Congressmen or Senator about FDA regulations?

Yes: 50 percent

No: 50 percent

Declined to Answer: 0

COMPANIES GENERATING $5-10 MILLION IN REVENUE (4 COMPANIES)

How has the company handled its FDA compliance process to date? (Mark all that apply)

Without Assistance: 0 percent

Hired an Attorney: 100 percent

Hired a non-legal Firm: 0 percent

Hired a Laboratory: 25 percent

Declined to Answer: 0

Has the company submitted a grandfather or substantial equivalence submission?

Yes: 50 percent

No: 50 percent

Declined to Answer: 0

Has the company met directly with FDA? (Mark all that apply)

Yes (In Person): 0 percent

Yes (Via Phone): 50 percent

Yes (Via Email): 25 percent

No: 50 percent

Declined to Answer: 0

Is there a person working at the company whose primary responsibility is FDA compliance?

Yes: 75 percent

No: 0 percent

Declined to Answer: 25 percent

Has the company increased prices directly due to FDA-related costs?

Yes: 75 percent

No: 25 percent

Declined to Answer: 0

Does the company intend on discontinuing products because of FDA deeming rules?

Yes: 25 percent

No: 75 percent

Declined to Answer: 0 percent

Has the company already discontinued products because of FDA deeming rules?

Yes: 25 percent

No: 75 percent

Declined to Answer: 0

How many SKUs did the company introduce prior to Aug. 8, 2016 with the intention of marketing them more fully at a later date?

Less than 100: 25 percent

100-500: 50 percent

500-1,000: 0 percent

More than 1,000: 25 percent

Declined to Answer: 0

Within the last 12 months has anyone from the company met directly with a U.S. Congressmen or Senator about FDA regulations?

Yes: 25 percent

No: 75 percent

Declined to Answer: 0

COMPANIES GENERATING OVER $10 MILLION IN REVENUE (6 COMPANIES)

How has the company handled its FDA compliance process to date? (Mark all that apply)

Without Assistance: 0 percent

Hired an Attorney: 100 percent

Hired a non-legal Firm: 16.67 percent

Hired a Laboratory: 33.33 percent

Declined to Answer: 0

Has the company submitted a grandfather or substantial equivalence submission?

Yes: 66.67 percent

No: 33.33 percent

Declined to Answer: 0

Has the company met directly with FDA? (Mark all that apply)

Yes (In Person): 16.67 percent

Yes (Via Phone): 50 percent

Yes (Via Email): 33.33 percent

No: 50 percent

Declined to Answer: 0

Is there a person working at the company whose primary responsibility is FDA compliance?

Yes: 66.67 percent

No: 33.33 percent

Declined to Answer: 0

Has the company increased prices directly due to FDA-related costs?

Yes: 50 percent

No: 50 percent

Declined to Answer: 0

Does the company intend on discontinuing products because of FDA deeming rules?

Yes: 66.67 percent

No: 16.67 percent

Declined to Answer: 0 percent

Has the company already discontinued products because of FDA deeming rules?

Yes: 33 percent

No: 66.67 percent

Declined to Answer: 0

How many SKUs did the company introduce prior to Aug. 8, 2016 with the intention of marketing them more fully at a later date?

Less than 100: 16.67 percent

100-500: 33.33 percent

500-1,000: 16.67 percent

More than 1,000: 33.33 percent

Declined to Answer: 0

Within the last 12 months has anyone from the company met directly with a U.S. Congressmen or Senator about FDA regulations?

Yes: 66.67 percent

No: 33.33 percent

Declined to Answer: 0

COMPANIES WHO DECLINED TO SPECIFY REVENUE (6 COMPANIES)

How has the company handled its FDA compliance process to date? (Mark all that apply)

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.

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This represents the two companies who declined to answer any questions.